Drug Interaction Study of Avanafil and Enalapril or Amlodipine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

A history or presence of significant cardiovascular (including thromboembolic disorders), neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator.

Any clinically significant laboratory abnormalities as judged by the Investigator.

A predisposition to priapism, such as subjects with sickle cell disease or blood dyscrasias.

Known history of cardiovascular or cerebrovascular event, or any history of angina.

History of fainting or vasovagal hypotension.

History or ECG evidence of any high-risk arrhythmia or ECG judged by the Investigator to be clinically significant.

Subjects with orthostatic hypotension (as evidenced by a reduction of 30 mmHg or more in systolic blood pressure, reduction of 20 mmHg or more in diastolic blood pressure, or evidence of cerebral hypoperfusion upon standing from a seated position).

Any history of bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.

Use of any prescription or over-the-counter (OTC) medication, including herbal products, within the 14 days prior to Day 1 and throughout the study. Up to 2 g per day of acetaminophen is allowed at the discretion of the Investigator.

Use of any drug in Appendix 1 (drugs known to interfere with metabolism by the CYP450 3A4 enzyme) within 30 days prior to Day 1.

Blood donation or significant blood loss within 56 days prior to Day 1.

Plasma donation within 14 days prior to Day 1.

Any use of tobacco or nicotine products within 6 months prior to Day 1.

Any subject who received an investigational drug within 30 days or six half-lives, whichever is longer, prior to Day 1.

Involvement in the planning and conduct of the study (applies to both VIVUS or designee staff, or staff at the investigational site).